Protocol for a Randomized Controlled Trial on Ultrasound-Guided Stellate Ganglion Acupuncture for Chronic Insomnia Disorder Utilizing fNIRS

Background

Chronic insomnia disorder (CID) affects 10-15% of adults globally and is associated with significant impairments in quality of life and daytime functioning. Current treatments, including cognitive behavioral therapy and pharmacotherapy, have limitations that may affect patient adherence.

Data Highlights

This trial will enroll 80 patients with CID, randomized into treatment and control groups, with outcomes assessed at baseline, week 4, and week 8.

Key Findings

• The trial will compare ultrasound-guided stellate ganglion acupuncture plus conventional acupuncture against conventional acupuncture alone.
• Primary outcomes include the Insomnia Severity Index (ISI) and fNIRS data of brain function.
• Secondary outcomes will assess sleep quality and anxiety using the Pittsburgh Sleep Quality Index (PSQI) and Hamilton Anxiety Rating Scale (HAMA).
• The study aims to explore treatment-related changes in brain function alongside clinical scales.

Clinical Implications

The findings from this trial may provide objective evidence for the efficacy of acupuncture-based treatments for CID. Understanding the neurofunctional mechanisms involved could enhance treatment strategies for insomnia.

Conclusion

This trial aims to clarify the potential benefits of combining ultrasound-guided stellate ganglion acupuncture with conventional acupuncture for patients with chronic insomnia disorder.

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5. AASM -- New guideline supports behavioral, psychological treatments for insomnia
6. VA/DoD -- 2025 Guideline for Insomnia
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8. https://www.healthquality.va.gov/HEALTHQUALITY/guidelines/CD/insomnia/I-OSA-CPG_2025-Guideline_final_20250915.pdf
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